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NCT07599644

Sepsis Multiomic Analysis & Risk sTratification in China

Sponsor: Yuebei People's Hospital

View on ClinicalTrials.gov

Summary

Objectives: 1. Perform Bulk RNA-seq transcriptome sequencing on enrolled samples to screen sepsis-specific mRNA diagnostic biomarkers and evaluate their diagnostic efficacy for early sepsis in the ICU; establish a molecular risk stratification system for sepsis based on mRNA expression profiles, and clarify the immunobiological characteristics, clinical manifestation differences, and prognostic risk levels of each stratification. 2. Integrate core indicators screened from transcriptome sequencing, open-source databases, and previous studies to establish and optimize an RT-LAMP rapid detection method for core sepsis targets, validate its diagnostic accuracy, specificity, and reproducibility, and construct a rapid sepsis diagnostic model adapted to bedside scenarios. 3. Integrate core indicators screened from open-source databases and previous studies to screen sepsis-specific diagnostic biomarkers in plasma and urine via PRM and metabolomics, complete protein/metabolic level validation using immunological methods (ELISA), construct a combined diagnostic model for sepsis, and complete internal validation and efficacy evaluation.

Official title: Sepsis Multiomic Analysis & Risk sTratification in China (China SMART-1): A Prospective Observational Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1400

Start Date

2026-06-20

Completion Date

2028-12-30

Last Updated

2026-05-20

Healthy Volunteers

No

Conditions

Locations (1)

Yuebei People's Hospital

Shaoguan, Guangdong, China